Scientific study performed to determine whether an investigational drug is safe and works in treating a particular disease. ‘Investigational’ means that the safety and effectiveness of the drug has not been approved by a regulatory authority for a specific clinical use, and the drug is still being studied. Clinical research studies also monitor any side effects that may develop while taking the investigational drug. Through these studies, pharmaceutical companies working with doctors can potentially find new ways to prevent, detect, diagnose, control and treat illnesses. Study participants are supported by an experienced and dedicated team of doctors, nurses and other healthcare professionals.
All investigational drugs must go through several phases of clinical research before they are made available to the public. All clinical research studies are monitored and approved by Institutional Review Boards/Ethics Committees. Clinical research studies are performed according to strict governmental and ethical guidelines. These guidelines help to ensure that patients’ rights are protected while information about the investigational drug is collected. The results of this study will help determine whether the investigational drug will be approved by a regulatory authority and/or go forward to the next stage of clinical development.
What are the phases of clinical research studies?
An investigational drug must pass three phases of clinical testing before it is approved by a country’s regulatory authority and made available to the public.
Phase 1 – The investigational drug is given to a small group of healthy volunteers or patients. Researchers look to see how much is safe to take and how the human body responds when it receives the investigational drug.
Phase 2 – The investigational drug is given to a small group of people with the disease or condition it is intended to treat. In this phase, researchers evaluate what dose is appropriate and begin to test whether the investigational drug is safe and works.
Phase 3 – Researchers test whether the investigational drug is safe and works in a larger group of participants over a longer period of time. Sometimes comparisons are made between the investigational drug and other medications that are already approved for the same purpose.
The LOTUS Study is in Phase 3.
What is informed consent?
Informed consent is the process through which you learn the most important facts about a clinical research study. Before participating, the study staff will take you through a written Informed Consent Form (ICF) for this study and answer any questions you may have. Before any procedures take place, you must understand, agree to and sign an ICF. This document explains the study in detail including potential risks and benefits and your rights and responsibilities while taking part in the study.
After you have read, understood and discussed all of the information about the study, you can decide whether or not to sign the form. The ICF is not a contract. You are free to leave the study at any time without penalty.
Should I take part?
Taking part in clinical research requires careful thought. Discuss your questions and concerns with the study team. You may also want to discuss the study with your healthcare provider. Before you decide whether to participate, make sure that you understand any potential risks involved; these will be explained to you by the study doctor. You should never feel obligated to participate in clinical research. You have the right to withdraw from the study at any time and for any reason. You will retain the right to the same standard of care you previously received. There will be no charge for any study-related care.
Why should I take part?
- Advance understanding
You are contributing to medical research that may help other people with SLE in the future.
- Study-related medical care
You will receive physical examinations and health check-ups.